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Computer System Validation Consultant
Arcondis Solutions s.r.o.
Place of work
Remote work
Remote work
Contract type
full-time
full-time
Start date
ASAP
ASAP
Wage (gross)
2 600 - 3 000 EUR/monthThe salary indicated is a tentative estimation and the final salary will be agreed after an interview, once we find out more about your experience, skills and personality.
2 600 - 3 000 EUR/monthThe salary indicated is a tentative estimation and the final salary will be agreed after an interview, once we find out more about your experience, skills and personality.
Information about the position
Job description, responsibilities and duties
Hello, we are looking for new members for the Arcondis family. This is your chance to make healthcare better. This opportunity will allow you to:
- Advise clients as a project manager or project team-member in the conception and implementation of software validation projects, hardware qualification projects and IT compliance projects in a regulated environment
- Implement IT compliance audit findings in the client environment
- Provide advice on the conception and implementation of new IT compliance requirements from the regulated environment as well as the conception and implementation of IT quality management systems
- Manage conception and implementation of IT quality management systems
- Support training & coaching in the field of computer system validation (CSV), hardware qualification and IT compliance
- Advise clients as a project manager or project team-member in the conception and implementation of software validation projects, hardware qualification projects and IT compliance projects in a regulated environment
- Implement IT compliance audit findings in the client environment
- Provide advice on the conception and implementation of new IT compliance requirements from the regulated environment as well as the conception and implementation of IT quality management systems
- Manage conception and implementation of IT quality management systems
- Support training & coaching in the field of computer system validation (CSV), hardware qualification and IT compliance
Employee perks, benefits
• Business mobile (also for private calls) and laptop
• Company bonus (based on company financial results)
• Referral bonus depending on level of person referred
• Heath-/Dentalcare costs coverage (up to 250EUR/year)
• Allowance for foreign languages classes/sport and leisure activities (up to 200EUR/year)
• 3 sick days per calendar year
• 2 extra days off for your wedding
• Social events (team-buildings and team-dinners)
• Budget for certifications and trainings (e.g. free access to 7000+ video trainings on www.pluralsight.com)
• Home Office (anywhere in Slovakia) upon agreement (possibility to work from Arcondis office in Kosice)
• Flexible Working Hours
• Become part of an established company with a start-up mindset (Self-organizing, flat hierarchy)
• Ice Hockey Tickets Discount (HC Kosice home games)
• Company bonus (based on company financial results)
• Referral bonus depending on level of person referred
• Heath-/Dentalcare costs coverage (up to 250EUR/year)
• Allowance for foreign languages classes/sport and leisure activities (up to 200EUR/year)
• 3 sick days per calendar year
• 2 extra days off for your wedding
• Social events (team-buildings and team-dinners)
• Budget for certifications and trainings (e.g. free access to 7000+ video trainings on www.pluralsight.com)
• Home Office (anywhere in Slovakia) upon agreement (possibility to work from Arcondis office in Kosice)
• Flexible Working Hours
• Become part of an established company with a start-up mindset (Self-organizing, flat hierarchy)
• Ice Hockey Tickets Discount (HC Kosice home games)
Information about the selection process
Please submit your application in English.
Thank you for applying to Arcondis!
Thank you for applying to Arcondis!
Requirements for the employee
Candidates with education suit the position
University education (Bachelor's degree)
University education (Master's degree)
Postgraduate (Doctorate)
University education (Master's degree)
Postgraduate (Doctorate)
Educational Specialization
IT
Language skills
English - Advanced (C1)
Experience in the position/sector
5
Number of years of experience
5
Personality requirements and skills
- Academic training in the field of business informatics, engineering, pharmaceuticals or a comparable subject
- Experience in performing multiple validations and / or hardware qualifications as a project member or project manager
- Very good knowledge of the underlying regulatory requirements (e.g. FDA, EU, GxP, ISO 13485, best practices GAMP5)
- Fluent written and spoken English
- Eager to learn
- Great communication skills
Nice to have:
- Jira and Confluence experience
- Programming skills (C++ or C# or another programming language skills) in order to review SW codes as part of validation activities
- Fluent written and spoken German
- Experience in performing multiple validations and / or hardware qualifications as a project member or project manager
- Very good knowledge of the underlying regulatory requirements (e.g. FDA, EU, GxP, ISO 13485, best practices GAMP5)
- Fluent written and spoken English
- Eager to learn
- Great communication skills
Nice to have:
- Jira and Confluence experience
- Programming skills (C++ or C# or another programming language skills) in order to review SW codes as part of validation activities
- Fluent written and spoken German
Advertiser
Brief description of the company
ARCONDIS is in the Top 10 of Consulting Companies in Health Care & Life Sciences in Switzerland. We are a global professional services company with an exclusive focus on the healthcare and life science industries, with their particularly demanding requirements on quality and regulatory affairs.
We have been addressing challenges and solving problems for our clients in the areas of compliance, business processes, information technology, and digital transformation since 2001.
We create value through cross-functional, sophisticated delivery methodologies and intelligent implementation.
Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.
We make healthcare better.
www.arcondis.com
We have been addressing challenges and solving problems for our clients in the areas of compliance, business processes, information technology, and digital transformation since 2001.
We create value through cross-functional, sophisticated delivery methodologies and intelligent implementation.
Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.
We make healthcare better.
www.arcondis.com
Number of employees
150-199 employees
ID: 4293439
Dátum zverejnenia: 23.11.2022
2022-11-23
lokalita: Remote work Pozícia: Compliance Specialist, ISO Specialist, Programmer, Quality Control/ISO Manager, Technical Writer Spoločnosť: Arcondis Solutions s.r.o.
Základná zložka mzdy (brutto): 2 600 EUR/month